| Primary Device ID | 00878953003023 |
| NIH Device Record Key | f89095f0-d9c6-4ec9-8f04-5853193025be |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Proximal Tool |
| Version Model Number | 72404120 |
| Company DUNS | 125111448 |
| Company Name | AMERICAN MEDICAL SYSTEMS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00878953003023 [Primary] |
| JCW | Prosthesis, Penis, Inflatable |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-02-13 |
| Device Publish Date | 2014-09-24 |
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